OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
NCT ID: NCT01945489
Last Updated: 2017-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
254 participants
INTERVENTIONAL
2013-10-28
2017-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OnabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Placebo/OnabotulinumtoxinA
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Normal saline
Normal saline (placebo) injected into the detrusor.
Interventions
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onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Normal saline
Normal saline (placebo) injected into the detrusor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
* Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
* Use of botulinum toxin therapy of any serotype for any urological condition
* Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
* History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
* Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Tamer Aboushwareb
Role: STUDY_DIRECTOR
Allergan
Locations
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Urologic Clinics of North Alabama
Huntsville, Alabama, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States
South Orange County Medical Research Center
Laguna Hills, California, United States
University of Southern California
Los Angeles, California, United States
Genesis Research LLC
San Diego, California, United States
U. Colorado, School of Med.
Aurora, Colorado, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Urology Associates of Norwalk
Norwalk, Connecticut, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Bladder and Prostate Health Investigations, LLC
Miramar, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Urology Health Team, PLLC
Ocala, Florida, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, United States
Northeast Indiana
Fort Wayne, Indiana, United States
Urogynecology Associates
Indianapolis, Indiana, United States
Deaconess Clinic, Inc.
Newburgh, Indiana, United States
Urology of Indiana, LLC
Noblesville, Indiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
Accumed Research
Garden City, New York, United States
Manhattan Medical Research
New York, New York, United States
Premier Medical Group of the Hudson Valley
Newburgh, New York, United States
Advanced Urology Centers of NY A division of IMP
Plainview, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, United States
Carolina Urology Partners, PLLC
Gastonia, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
Institute of Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Urologic Consultants of Southern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
State College, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Virginia Women's Center
Richmond, Virginia, United States
Virginia Urology
Richmond, Virginia, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States
The Polyclinic
Seattle, Washington, United States
Countries
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References
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McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.
Other Identifiers
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GMA-OAB-113
Identifier Type: -
Identifier Source: org_study_id